BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1082638 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02070
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. ALL UNITS SHIPPED FOR THE BATCH CONFORMED TO PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE STENT WAS DAMAGED. THE PROXIMAL RCA (RIGHT CORONARY ARTERY) LESION HAD 99% STENOSIS WITH A HARD CALCIFICATION AND MODERATE TORTUOSITY. THE PHYSICIAN FELT THAT THE 3.0X32MM TAXUS EXPRESS2 DRUG ELUTING STENT CAUGHT ON THE LESION WHILE HE ADVANCED THE STENT DELIVERY SYSTEM TO THE LESION. THE PHYSICIAN NOTICED THAT A STENT STRUT HAD LIFTED UP WHEN THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS AND THE PT WAS REPORTED TO BE GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.0X32MM 0011520707

    Patients

    Seq Age Sex Outcome Treatment
    1